Lawsuit Overview
Settlement Overview
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November 5, 2009 - The court ordered the authorization of the distribution of the net settlement fund.
May 28, 2008 - The court approved the settlement and the plan of allocation, granted in part and denied in part the motion for attorneys’ fees and expenses, and dismissed the action with prejudice.
November 5, 2007 - The court issued an amended order on the preliminary approval order.
October 30, 2007 - The court preliminarily approved the settlement.
August 13, 2007 - Parties filed a stipulation of settlement.
September 30, 2005 - The court granted in part and denied in part the defendants' motion to dismiss.
December 27, 2004 - The defendants filed a motion to dismiss.
December 6, 2004 - A defendant filed a motion to dismiss.
October 4, 2004 - The lead plaintiffs filed an amended consolidated complaint on behalf of investors who purchased Genta Incorporated (NASDAQ: GNTA) common shares between December 14, 2000 and May 3, 2004. The lead plaintiffs allege that the defendants violated the Securities Exchange Act of 1934 by issuing false and misleading statements between December 14, 2000 and May 3, 2004.
August 2, 2004 - The lead plaintiffs and lead counsel were appointed and all cases were consolidated.
July 6, 2004 - Additional lead plaintiff motions were filed.
July 5, 2004 - Another lead plaintiff motion was filed.
July 2, 2004 - A lead plaintiff motion was filed.
June 1, 2004 - Another investor filed a complaint in the U.S. District Court for the District of New Jersey on behalf of investors who purchased Genta Incorporated (NASDAQ: GNTA) common shares between February 24, 2003 and May 3, 2004.
May 12, 2004 - An additional investor filed a complaint.
May 6, 2004 - Another investor filed a complaint.
May 4, 2004 - An investor in shares of Genta Incorporated (NASDAQ: GNTA later trading on the OTC sheets as GNTAQ) filed a lawsuit in the U.S. District Court for the District of New Jersey against Genta Incorporation over alleged violations of Federal Securities Laws in connection with certain allegedly false and misleading statements made between September 10, 2003 and May 3, 2004.
The complaint alleges that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder. The complaint alleges that, between September 10, 2003 and May 3, 2004, Genta Incorporated and certain of its officers and directors falsely represented to the investing public that Genasense did not appear to be associated with serious adverse reactions in the Phase 3 clinical trial. However, unknown to the public, the use of Genasense was associated with increased toxicity and discontinuations due to adverse events which seriously threatened FDA approval of the drug, particularly in light of the marginal benefits associated with the drug. By reason of the testing of Genasense, Genta Incorporated knew or should have known of the following events: (a) 69 (18.6%) patients discontinued therapy for adverse events on the G3139 arm versus 39 (10.8%) on the DTIC arm alone; (b) the rate of serious adverse events was 40% on the G3139 arm versus 27% on DTIC alone; (c) all toxicities were more frequent on the Genasense arm; (d) the frequency of grade 3-4 adverse events, serious adverse events and treatment emergent adverse events leading to discontinuation were all higher on the Genasense arm; (e) the incidence of thrombocytopenia, a serious bleeding disorder characterized by a marked decrease in the number of blood platelets, was 28.8% in the Genasense arm, compared with 11.1% in the DTIC arm; (f) pyrexia (fever) was three times as frequent on the Genasense arm with 53.1% in the Genasense arm, compared to 17.5% on the DTIC arm; (g) neutropenia (significantly reduced white blood cells) and anorexia were twice as frequent with Genasense; (h) upper extremity thrombosis (blood clots) occurred in 5% of the patients receiving Genasense, compared with .8% of the patients receiving DTIC alone; (i) in the Genasense arm, 18.6% of patients discontinued treatment permanently, compared with 10.8% on the DTIC arm; and (j) since the dosing of DTIC was identical on the two arms, toxicity increases were due to the addition of G3139.
On September 10, 2003, Genta Incorporated announced the results of the Phase 3 clinical study of Genasense and submitted the first portion of the NDA to the FDA. The NDA was completed on December 8, 2003 and on February 6, 2004, Genta Incorporated announced that the FDA had accepted the NDA. In addition, Genta Incorporated announced on February 6, 2004 that the FDA granted priority review status to the application. On April 30, 2004, the staff of the Oncologic Drugs Advisory Committee (ODAC) of the FDA stated in briefing materials in advance of the May 3, 2004 ODAC meeting that the Phase 3 clinical trial of Genasense failed to demonstrate a survival benefit, which was the primary trial endpoint. However, small but unreliable benefits were seen for progression-free survival (PFS) and response rates (RR). The staff also stated: Uncertainty also exists regarding whether an improvement in PFS and RP of this magnitude outweighs the increase in toxicity seen with the combination (of Genasense and dacarbazine.). Survival was not improved and toxicity was increased. As a result of this April 30th announcement, the price of Genta Incorporated shares (NASDAQ: GNTA) dropped $5.83 or 40.4% to close at $8.60 on the Nasdaq market on an unusually high volume of over 30 million shares traded.
On May 3, 2004, the ODAC ruled by a 13-3 vote that, in the absence of increased survival, the evidence presented did not provide substantial evidence of effectiveness to outweigh the increased toxicity of Genasense. As a result of this announcement, the price of Genta Incorporated shares fell more than $3 per share, to close at $5.11 on May 3, 2004 at a high volume of over 17 million shares traded.